Table 1.
Baseline patient demographics and clinical characteristics in the ITT population (n = 459)
| Characteristic | Pexa-vec + sorafenib (n = 234) | Sorafenib (n = 225) |
|---|---|---|
| Age, years | ||
| n | 234 | 225 |
| Median | 62 | 61 |
| Range | 35–84 | 28–84 |
| Sex, n (%) | ||
| Male | 204 (87.2) | 182 (80.9) |
| Female | 30 (12.8) | 43 (19.1) |
| Region**, % | ||
| Asian | 127 (54.3) | 129 (57.3) |
| Non-Asian | 107 (45.7) | 93 (42.7) |
| Race, n (%) | ||
| White | 71 (30.3) | 69 (30.7) |
| African American | 8 (3.4) | 6 (2.7) |
| Asian | 145 (62.0) | 134 (59.6 |
| Native Hawaiian/other Pacific Islander | 4 (1.7) | 5 (2.2) |
| Other | 6 (2.6) | 11 (4.9) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 5 (2.1) | 6 (2.7) |
| Not Hispanic or Latino | 229 (97.9) | 219 (97.3) |
| BCLC stage, n (%) | ||
| B – intermediate | 84 (35.9) | 73 (32.4) |
| C – advanced | 150 (64.1) | 151 (67.1) |
| Missing | 0 | 1 (0.4) |
| Body mass index, kg/m2 | ||
| n | 218 | 213 |
| Mean (SD) | 19.782 (28.5548) | 18.573 (28.8455) |
| Median | 24.279 | 24.355 |
| Range | 15.06–44.25 | 13.91–49.88 |
| Time since initial diagnosisa, months | ||
| n | 234 | 225 |
| Mean (SD) | 19.782 (28.5548) | 18.573 (28.8455) |
| Median | 7.627 | 6.312 |
| Range | 0.13–146.63 | 0.07–204.46 |
| Tumor size (SLD) of target tumors (RECIST 1.1) | ||
| n | 228 | 217 |
| Mean (SD) | 125.23 (71.339) | 120.74 (75.029) |
| Median | 114.50 | 111.00 |
| Range | 11.0–349.0 | 12.0–479.0 |
| Tumor size (SLD) of target tumors (mRECIST) | ||
| n | 218 | 206 |
| Mean (SD) | 100.82 (62.835) | 99.85 (65.356) |
| Median | 89.00 | 89.00 |
| Range | 10.0–337.0 | 12.0–322.0 |
| AFP levels, ng/mL | ||
| n | 234 | 225 |
| Mean | 19,594.53 (77,469.303) | 20,791.32 (63,783.454) |
| Median | 191.80 | 187.56 |
| Range | 1.2–882,865.4 | 1.1–453,514.0 |
| ECOG performance status, % | ||
| 0 | 146 (62.4) | 142 (63.1) |
| 1 | 88 (37.6) | 83 (36.9) |
| Extrahepatic disease**, % | ||
| Present | 96 (41.0) | 96 (42.7) |
| Not present | 88 (37.6) | 83 (36.9) |
| Vascular invasion**, % | ||
| Present | 81 (34.6) | 79 (35.1) |
| Not present | 153 (65.4) | 146 (64.9) |
| Etiology of the diseaseb, n (%) | ||
| Hepatitis B | 122 (52.1) | 114 (50.7) |
| Hepatitis C | 53 (22.6) | 57 (25.3) |
| ETOH | 47 (20.1) | 40 (17.8) |
| NASH | 17 (7.3) | 25 (11.1) |
| Other | 26 (11.1) | 18 (8.0) |
| Missing | 4 (1.7) | 4 (1.8) |
| Prior HCC therapies, n (%) | ||
| Surgical resection | 72 (30.8) | 75 (33.3) |
| Local-regional therapy | ||
| TACE | 102 (43.6) | 85 (37.8) |
| PEI | 4 (1.7) | 2 (0.9) |
| RFA | 38 (16.2) | 23 (10.2) |
| CA | 1 (0.4) | 0 |
| Radiation therapy | ||
| Stereotactic | 8 (3.4) | 3 (1.3) |
| Conformational | 5 (2.1) | 5 (2.2) |
| Brachytherapy | 0 | 1 (0.4) |
| Prior therapyc (≤7 days) | 132 (56.4) | 128 (56.9) |
SLD, sum of longest diameter; AFP, alpha-fetoprotein; BCLC, Barcelona Liver Clinic Liver Cancer; SD, standard deviation; ETOH, ethyl alcohol; NASH, non-alcoholic steatohepatitis; HCC, hepatocellular carcinoma; RFA, radiofrequency ablation; TACE, transarterial chemoembolization; PEI, percutaneous ethanol injection; CA, cryoablation.
**Based on IVRS. aDefined as the date of HCC diagnosis to date of randomization.
bPatients could have multiple etiologies; therefore, the total could be greater than 100%.
cDefined as any therapy such as sorafenib, HCC radiation therapy, HCC local-regional therapy of ≤7 days duration.